FDA rejects Avanir's migraine spray; Kite raising $138M for CAR-T development;

@FierceBiotech: After numerous setbacks, $LLY mounts another pivotal assault on Alzheimer's. More | Follow @FierceBiotech

@JohnCFierce: Takeda gets a BTD designation on ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. | Follow @JohnCFierce

@DamianFierce: In which hackers trick bankers into tipping them off to biopharma buyouts. Story | Follow @DamianFierce

> The FDA rejected Avanir's ($AVNR) AVP-825, a drug-device combo designed to treat migraines, asking the company to conduct another study to determine the technology's user-friendliness. More

> Chinese biotech CARsgen completed an undisclosed A round to finance its work in CAR-T immunotherapies for a variety of cancers. Teaming up with the Shanghai Cancer Institute and Shanghai Renji Hospital, the company plans to spend its funding on clinical trials for its lead therapy, targeting hepatocellular carcinoma. News

> Kite Pharma ($KITE) is looking to raise $138 million in a follow-on offering, money that will support its development of CAR-T cancer treatments and the construction of its own commercial manufacturing facility. S-1

> Dynavax ($DVAX) has regained the rights to the failed treatment DV1179 after partner GlaxoSmithKline ($GSK) let its license expire. The drug missed its primary endpoint in a Phase Ib/IIa study in lupus, but Dynavas believes it may have a promising future in inflammatory disease like autoimmune pancreatitis and nonalcoholic steatohepatitis. Item

> Actavis ($ACT) and Germany's Grünenthal have terminated their collaboration on cebranopadol, a small-molecule pain drug. Grünenthal first partnered with Forest Laboratories, since acquired by Actavis, in 2010, handing over U.S. and Canadian rights in the process. Grünenthal now intends to continue cebranopadol's development as planned, working with Actavis to transition ongoing trials without interruption. Statement

Medical Device News

@FierceMedDev: ICYMI: U.K. and Wellcome Trust back trial of new, 15-minute Ebola test in West Africa. FierceDiagnostics article | Follow @FierceMedDev

@EmilyWFierce: Merck KGaA will hold onto its consumer health biz--for now. FiercePharma story | Follow @EmilyWFierce

> Harvard researchers using 3-D printing to create customized airway stents. Report

> Philips to focus on informatics as part of HealthTech restructure. Story

> Study shows artificial pancreas improves treatment for Type 1 diabetes. Article

Pharma News

@FiercePharma: Zoetis R&D chief Catherine Knupp on the fight to stay atop animal health. FierceAnimalHealth article | Follow @FiercePharma

@CarlyHFierce: UPDATED with a statement from $NVS - Novartis flu vaccine under the lens as Italy probes 13 deaths. Article | Follow @CarlyHFierce

> Reuters: In Fresenius, Danone could lose second suitor for nutrition unit. Item

> GSK ready to ax hundreds in U.S., sources tell Bloomberg. Story

> Novartis flu vaccine under the lens as Italy probes 13 deaths. Article

> Merck KGaA will hold onto its consumer health biz--for now. Report

CRO News

> Almac partners up to keep patients--and data--safe in trial emergencies. More

> WuXi pairs up with deCODE spinout to further its genomics expansion. News

> GVK gets its drug repurposing tech into Japan with new partnership. Story

> Quintiles pools postmarketing services into a single offering. Item

> Accovion reaches into France amid expansion kick. Article

Biotech IT News

> U.K. heavyweights commit $16M to Oxford Uni genome data analysis spinout. Report

> Texas' $3B cancer agency makes computational biology a priority. News

> Nvidia backs projects to tap GPUs for cancer research. Story

> Humana agrees to contribute information to PearlDiver's database. Article

> Monocl Software bags grant for KOL assessment platform. More

Animal Health News

> Bayer launches smartphone app to help farmers monitor dairy herd health. Story

> Natura Pet issues 8-state voluntary recall of cat food; Canada included. More

> IDEXX aids in discovery of new biomarker to spot early kidney disease in cats. Item

> Dutch set safety corridor as a bird flu hits a fourth poultry farm. News

> Nova Scotia establishes program to support beef industry and safety standards. Article

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